An interventional study of Empagliflozin and Anakinra in Postprandial Hypoglycemia, Bariatric Surgery and Late Dumping Syndrome, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-24.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Diagnostic
The purpose of the study is to investigate whether hypoglycaemia observed after food intake in bariatric patients can be either influenced by an SGLT2 inhibitor, empagliflozin, or via inhibition of inflammation with an human interleukin-1 receptor antagonist (IL1-RA, anakinra).
Postprandial hypoglycemia also referred as late-dumping after bariatric surgery can be clinically asymptomatic but also life-threatening. The exact mechanisms leading to postprandial hypoglycemia are not fully understood and therapeutic options are limited and often accompanied with reduced life-quality and weight gain.
In this study, prospective, randomly selected and double-blinded treatment is performed to investigate the effect on postprandial hypoglycemia. A total of 12 subjects participate in the study. After a screening date, three study dates will be performed. Participation in the study usually takes two weeks, but can also be extended to three weeks in individual cases. The University Hospital Basel will be the only test center in this study.
In order to check whether the increase in blood glucose after food intake and subsequent excessive reaction of the body followed by hypoglycaemia patients receive either anakinra as a subcutaneous injection 3h or empagliflozin as a tablet 2 h before a liquid standardized test meal. On one study day only subcutaneous and oral placebo control will be used.
At the beginning of each study date as well as at the time of the test meal several blood samples will be taken to evaluate blood glucose and blood glucose-influencing parameters (insulin / C-peptide, intestinal hormones, inflammatory parameters such as C-reactive protein, IL1beta and IL1-receptor agonist as well as macrophage and t-lymphocyte subpopulations) will be controlled. Questionnaires for dumping symptoms (Dumping Rating scale, Sigstad Score) and hypoglycemia testing with mini-mental test, stanford sleepiness scale and Edinburgh Hypoglycemia Scale will be performed repetitively.
Exclusion Criteria:
subcutaneous placebo (0.67 ml of 0.9% sodium chloride) 3 hours before the test meal and an oral placebo (winthrop tablet) 2 hours before the test meal will be administered by an Independent nurse to the blinded patient
Other: oral placebo (winthrop tablet) · Other: subcutaneous placebo (0.67 ml of 0.9% sodium chloride)
subcutaneous placebo (0.67 ml of 0.9% sodium chloride) 3 hours before the test meal and an 10mg of empagliflozin 2 hours before the test meal will be administered by an independent nurse to the blinded patient
Drug: Empagliflozin · Other: subcutaneous placebo (0.67 ml of 0.9% sodium chloride)
subcutaneous injection of 100mg anakinra 3 hours before the test meal and an oral placebo (winthrop tablet)before the test meal will be administered by an Independent nurse to the blinded patient
Drug: Anakinra · Other: oral placebo (winthrop tablet)
Glucose lowering effect of empagliflozin for reducing the counter-regulatory glucose-lowering response
IL-1Beta blockage effect on insulin secretion and thereby influencing postprandial glucose level
subcutaneous placebo (0.67 ml of 0.9% sodium chloride) 3 hours before the test meal and an oral placebo (winthrop tablet) 2 hours before the test meal will be administered by an Independent nurse to the blinded patient
subcutaneous placebo (0.67 ml of 0.9% sodium chloride) will be administered in arm 'Placebo-Placebo' and arm 'drug: Empagliflozin'
Postprandial hypoglycemia in patients after bariatric surgery
To assess whether empagliflozin or anakinra compared to placebo reduce the severity of hypoglycemia (i.e. change of blood glucose level in mmol/l) following a mixed-meal in patients after bariatric surgery.
Time frame: 6 hours
change of C-peptide
plasma level of c-peptide with anakinra or empagliflozin in comparison to placebo
Time frame: 6 hours
plasma level of IL-1Beta
plasma level of IL-1Beta with anakinra or empagliflozin in comparison to placebo
Time frame: 6 hours
plasma level of Glucagon-like Peptide1 (GLP1)
plasma level of GLP1 with anakinra or empagliflozin in comparison to placebo
Time frame: 6 hours
change of glucagon level
plasma level of glucagon with anakinra or empagliflozin in comparison to placebo
Time frame: 6 hours
changes in Edinburgh Hypoglycemia Scale
changes in Edinburgh Hypoglycemia Scale with anakinra or empagliflozin in comparison to placebo
Time frame: 6 hours
amount of glucose needed for restoring normoglycemia
amount (gramme) of glucose needed for restoring normoglycemia with anakinra or empagliflozin in comparison to placebo
Time frame: 6 hours
length of time needed for restoring normoglycemia
length of time (minutes) needed for restoring normoglycemia with anakinra or empagliflozin in comparison to placebo
Time frame: 6 hours
Plan to share: No
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University Hospital, Basel, Switzerland